A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine

This study has been completed.
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Pakit Vichyanond, MD, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01432522
First received: January 19, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.


Condition Intervention
Anaphylaxis
Drug: Epinephrine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection

Resource links provided by NLM:


Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • Composite of Pharmacokinetics of epinephrine [ Time Frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose ] [ Designated as safety issue: Yes ]
    Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route


Secondary Outcome Measures:
  • Numbers of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Any side effects from such administration such as bad smelling, sorethroat.


Estimated Enrollment: 12
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epinephrine IN, epinephrine IM, saline IN
  1. Intranasal saline
  2. Intramuscular epinephrine
  3. Intranasal epinephrine
Drug: Epinephrine
  1. Intranasal epinephrine 5 mg /spray
  2. Intramuscular epinephrine 0.3 mg
  3. Intranasal saline spray
Other Name: adrenaline

Detailed Description:

Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subjects
  2. 18-30 years-old

Exclusion Criteria:

  1. Pregnancy
  2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432522

Locations
Thailand
Facaulty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Mahidol University
Investigators
Study Director: Pakit Vichyanond, MD. Siriraj medical school, Mahidol Univrsity
  More Information

Publications:
Responsible Party: Pakit Vichyanond, MD, Professor of Pediatrics, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01432522     History of Changes
Other Study ID Numbers: 078/2550
Study First Received: January 19, 2011
Last Updated: September 12, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Siriraj Hospital:
Intranasal epinephrine
Plasma epinephrine level

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014